MAUDE Adverse Event Report: ROCHE DIAGNOSTICS INTERNATIONAL LTD. COBAS 8100; CALCULATOR / DATA PROCESSING MODULE

Model Number COBAS 8100

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device-Device Incompatibility (2919); Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/13/2019

Event Type  malfunction  

Event Description

Non-centrifuged blood collection tubes are not identified by the roche cobas 8100 preanalytical system, and the specimen is sampled and tested by the cobas 8000 analytical system for many clinical chemistry tests producing erroneous test results.The sample check module on the cobas 8100 system cannot identify non-centrifuged specimens, according to roche personnel.There are many tests that are affected by sampling and testing from non-centrifuged tubes.Some routine clinical chemistry tests that are of importance with non-centrifuged tubes are the analytes found in high concentrations within red blood cells.Since non-centrifuged specimens have a higher number of red blood cells in the plasma or serum compartment compared to centrifuged specimens, the concentrations of analytes found within the red blood cells will be increased in the plasma or serum specimens.In addition to increase in red blood cell intracellular analytes in the plasma or serum compartments due to non-centrifuged specimens being sampled and tested on the roche cobas 8000 analytical system, the resulting release of hemoglobin from the red blood cells can cause the spectral interference by affecting the absorbance readings used to measuring concentrations of other analytes in plasma or serum and inhibit chemical reactions used to measuring analytes.The release of intracellular enzymes from red blood cells can affect assay methodologies, and water with the red blood cells can dilute plasma or serum constituents due to non-centrifuged tubes.The roche cobas 8100 system should identify and place the non-centrifuges tubed in the error tray on the preanalytical system to avoid these non-centrifuged tubes from being pipetted and tested on many different chemistry assays on the roche cobas 8000 analytical system, which produces erroneous test results and may affect pt safety and mgmt.Specifically, the roche cobas 8100 preanalytical line should have a "spin status detection" technology similar to that on the roche p512 and p612 preanalytical system.The spin status detection uses lasers to determine a few parameters on the tube like the presence of the separating gel and its position within the tube.The spin status is not described for the cobas 8100 preanalytical system on roche's product info sheet; please see attached material.Roche personnel has not discussed the spin status detection technology with stanford lab personnel.The clia total allowable error for the above analytes are listed below.I have included the recent changes to the clia limits.In practice, the total allowable error for a given analytical method must be less than the clia limits stated below.I typically look at values greater than 2.77 x sd of qc materials for each analyte to determine the clinically significant change in test results between non-centrifuged and centrifuged tubes; thus, the difference between non-centrifuged and centrifuged specimens test results on the same pt that exceed the values.There are some issues with the spin status detection technology like it is not able to distinguish between whole blood and blood clot from centrifugation and between centrifuged sample and not centrifuged sample after standing (blood cell may settle when going through the line to the cobas 8000 analytical modules) in the absence of gel.Since we cannot identify all the unspun tubes by our current strategies we do not know the frequency of unspun specimens.Furthermore, results may be (are) released from unspun specimens that do not fail any of our autoverification parameters.

• Brand Name: COBAS 8100
• Type of Device: CALCULATOR / DATA PROCESSING MODULE
• Manufacturer (Section D): ROCHE DIAGNOSTICS INTERNATIONAL LTD.
• MDR Report Key: 8830956
• MDR Text Key: 152634548
• Report Number: MW5088385
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/06/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: COBAS 8100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/25/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other